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What’s Wrong with the Tester Amendments

On April 14, 2010, Senator Jon Tester (D-MT) announced that he is introducing two amendments to the FDA Food Safety Modernization Act, S. 510. The aim of the amendments is to ease the burden that small farmers believe the bill will impose on them if passed. The amendments, if adopted, will exclude facilities with adjusted gross incomes of less than $500,000 from certain safety plan and traceback requirements, and will exclude facilities that primarily sell directly to consumers, hotels, restaurants, or institutions from certain produce safety requirements.

Senate Bill 510, since introduced, has been controversial amongst many in the local food movement. Many of the bill’s vocal opponents have stated that S. 510’s new Hazard Analysis and Risk-Based Preventive Controls, traceback, and produce safety requirements, if passed, will result in a crushing blow to the sustainability of small farms. Some extremist websites have even gone as far as to publish headlines claiming that “Senate Bill S. 510 Makes it illegal to Grow, Share, Trade or Sell Homegrown Food, or Even to Produce Your Own Food.” For the most part, however, it appears that a good number of small farmers will support S. 510, as long as it includes the Tester amendments. Whether consumers should support the amendments is a whole different story.

The first of Senator Tester’s amendments excludes facilities that have an average annual adjusted gross income for the previous three-year period of less than $500,000 from federal Hazard Analysis and Risk-Based Preventive Controls (Section 418) regulations, deferring to state law. From the consumer’s standpoint, this is perhaps the least worrisome of the three proposed amendments. While all farms should be required to develop and maintain preventive controls, a one size fits all approach does not seem appropriate. Add to that the fact that Section 418 does not limit the FDA’s authority to issue category-specific HACCP plans (See pg. 137, line 3), and it would seem that, even if small farms are exempt, the federal government will still be able to require safety plans for particularly hazardous categories of food, regardless of the facility’s income.

Even though Senator Tester’s amendment to Section 418 appears to be the least worrisome of his proposed actions, it is not without its faults. The primary risk associated with allowing Hazard Analysis and Risk-Based Preventive Controls regulations to be dictated by state law is the piecemeal basis on which they will be assembled. Laws can vary significantly from state to state; this is especially dangerous when coupled with the fact that Senator Tester’s amendment to Section 418 mentions nothing about food products that are shipped across state lines. By adopting Senator Testor’s amendments, the federal government would essentially forgo an opportunity to adopt a national standard for Hazard Analysis and Risk-Based Preventive Controls. The end result is that consumers will walk into their local grocery stores and not know whether the produce that they are purchasing came from a state with strict preventive controls requirements or not. Perhaps some might see this as an argument in favor of shopping at farmer’s markets, but it is irresponsible to ignore the fact that the majority of this nation’s citizens purchase their food from large supermarkets and deserve to be assured of the safety of that food.

The second provision of Senator Tester’s amendments limits recordkeeping requirements for facilities that have an average annual adjusted gross income for the previous three-year period of less than $500,000. Specifically, the amendment requires only that records be kept for transactions with a qualifying facility’s immediate suppliers and immediate subsequent recipients. This amendment would result in an enormous setback in the push for national traceability requirements. As previously discussed on Food Safety News, the $500,000 cutoff would exempt nearly 95 percent of all domestic farms from S. 510’s stricter traceability standards, virtually eliminating the effectiveness of the new requirements. Unfortunately, as many in the food safety industry well know, delays in traceback efforts can often lead to many unfortunate illnesses and deaths during foodborne illness outbreaks.

The final provision of Senator Tester’s amendments excludes facilities from S. 510’s produce safety requirements if the qualifying facility’s annual value of sales of food directly to consumers, hotels, restaurants, or institutions exceeds the annual value of sales of food to all other buyers. The specific provision which this amendment addresses, Section 419, requires proposed rulemaking “to establish science-based minimum standards for the safe production and harvesting of those types of fruits and vegetables that are raw agricultural commodities for which the Secretary has determined that such standards minimize the risk of serious adverse health consequences or death.” This provision is one of the most straightforward measures in the entire Senate bill; why small farmers should be exempt from updated produce safety procedures is beyond me.

The primary argument that I have thus far seen raised against Section 419 is that the public hearing requirements (“not fewer than three public meetings in diverse geographical areas of the United States”) are too limited and may occur during harvest season. This argument fails to acknowledge the fact that the federal government is required, under the Administrative Procedures Act (APA), to allow for the “submission of written data, views, or arguments.” (See U.S.C. § 553(c)). Oral presentations, such as those invited by the public meetings, are not required under the APA and are offered as a mere courtesy. Thus, if a rule is proposed pursuant to Section 419, any member of the public will be allowed to submit written comments at his or her own convenience.

While small farmers should be legitimately concerned with some of the one size fits all proposals contained in Senate Bill 510, changes to the bill should not come at the expense of consumer safety. Senator Tester’s amendments, therefore, need more thought and retooling before the Senate should consider incorporating them into the final bill. Additionally, the Senate should be quite weary of the commonly held misconception that small farms are inherently safe. To quote Senator Tester himself, “Let’s face it, dangerous food-borne outbreaks don’t start with family agriculture.” Small farms are not inherently safe simply by virtue of their diminutive size. Case in point was the 2006 E. coli O157:H7 spinach outbreak. That outbreak, which resulted in 205 illnesses and 3 deaths and spanned 26 states, was caused by spinach that was grown in one field on a 50-acre farm in San Benito County, California. The danger of such an incident happening again is very real, and so it remains that exempting small farms from risk prevention, traceability, and produce safety requirements is not the answer.

I say all of this as an ardent supporter of the local food movement. Local growers must never lose sight of the fact that their responsibilities are to their consumers. Those consumers deserve to be assured that all of the food that they purchase is held to a stringent national safety and traceability standard.

This article is correct in that a “One Size Fits All” protocol is incorrect. And, we must be very careful in not ascribing too much value to the Hazard Analysis system to which this article refers, which is HACCP. While Pillsbury-style HACCP is indeed science based and produces consistently wholesome food, USDA-style HACCP is NOT based in science, and has been intentionally implemented in a manner which insulates the huge transnational slaughter facilities from meaningful oversight. Simultaneously, and this is enormously important in the discussion over S. 510, USDA-style HACCP has decimated our domestic countryside of small meat plants. Such plants did not drop federal inspection because of their inability to produce safe meat. Rather, they became so exasperrated in ever-changing USDA demands, most of which are unjustified and have no connection to food safety, that the plant owners walked away. The same sordid scenario is guaranteed to occur once S. 510 is passed as written, and we will have only ourselves to blame as we are unwilling to admit in advance that this federal boon doggle will repeat itself. We will also increase our dependence on imported produce; please don’t attempt to convince me that foreign produce manufacturers have a system “equivalent” to ours. Senator Tester’s ammendments are not only common sense, but necessary.
John Munsell

Heather

A 50 acre feild of spinach is not the type of small farm most small farmers are worried about. It is people like me who grow at most 1/4 acre of one item (onions in my case) with most of my production limited to a couple hundred feet of 100 diffrent items, each one requireing it’s own chapter in your Hazard plan, 3 acres of veggies and a filing cabinet of regulation. The small diversified farmer’s paperwork requirement is more then the large conventional mono-culture growers.
These are the farms most people visit at farmers markets or join CSAs from and these are the farms who will be potentially devistated by this bill without ammendments.
The “evidence based” standards are also terrifing, as they place constiantly moving target on the farmer who is struggling to make $25,000 or $30,000 a year through 12 hour days. Take for instance the “wildlife exclusion zones” in the california leafy greens marketing agreement (widely recognized as a “model”.) These 200 foot buffers would wipe out possible growing areas for farmers with less then about 50 acres. Our 30 acre farm would have no land that would be farmable. Say good buy to 1/2 acre urban farms (only 100 feet wide to start with!)
Farms are NOT factories. Period. Food grows in dirt, not in a sterile medium. One size does not fit all, but without ammendment the law has no requirement for any thing else.

Larry Andrew

As a consumer as well as one whose wife was poisoned with salmonella, I am sensitive to both points of view. I am particularly persuaded by the argument against a “one size fits all” approach. Further, given the deadly potential of poisoning from any size grower or supplier, we also need some type of consistent application of food safety regulations to all suppliers to consumers. It is illogical to have state regs on growers who supply through interstate commerce.
After a year or so following this issue I am convinced that financial and criminal sanctions can be used effectively to motivate producers and processors to cause them to place more emphasis on food safety. If Heather is required to insure for damages that may be caused by her produce, and if she is subject to criminal charges for knowingly introducing contaminated products to the market, she and insurance companies will be more likely to focus on effective food safety practices.

hhamil

Alex, your labeling a website as “extremist” because it wrote “Senate Bill S. 510 Makes it illegal to Grow, Share, Trade or Sell Homegrown Food, or Even to Produce Your Own Food” made me LOL.
The problem the writer on the website has is that s/he believes the plain meaning of words and that laws should be clearly written. What naiveté.
The new subsection 419(a)(1) created by Sec. 105 Standards for Produce Safety states that the Secretary of HHS shall “establish science-based minimum standards for the safe production and harvesting of those types of fruits and vegetables that are raw agricultural commodities for which the Secretary has determined that such standards minimize the risk of serious adverse health consequences or death.” And then, subsection 105(b) follows with “Prohibited Acts- Section 301 (21 U.S.C. 331), as amended by section 103, is amended by adding at the end the following: (vv) The failure to comply with the requirements under section 419.'”
This says the Secretary of HHS, whose department doesn’t know squat about growing crops and animals, sets rules for the “production” and “harvesting” not just for the “sale” of food. That’s what I do when I grow a garden, Alex. It plainly says I will have to obey the rules they set. So, where exactly in the law is this restricted so it can’t be applied as the “extremist website” says?
This is one of the core problems with S 510; it places farmers in the middle of an endless swamp of regulation and rule making. Instead of learning more about farming and ranching, we will have to learn about rules so we can prove we are obeying them.
Big can always pay the price of regulation and rule making. Small frequently cannot.
The even more fundamental problem with what you’ve written, Alex, is that you accept a priori the need for regulation of small ag. But then advocates of the industrial-size-fits-all food safety regulation also declare a priori that what S 510 is “prospective” and “science-based!” What crap and poor analysis.
If any reader wants to actually discuss Sen. Tester’s amendments or S 510, I’ll be happy to do so. Just write me at healthyfoodcoalition@gmail.com and we’ll set up a time to talk on my nickel.

Judith McGeary

Unfortunately, the author has confused two distinct issues.
1) The HACCP and traceability requirements apply to “facilities.” This term excludes “farms” unless they do processing. Many farms do some procesing (making jams or dried fruits, for example) but not all.
So the claim that the $500,000 threshold will exempt “95% of all domestic farms” is simply wrong. The threshold applies to facilities, not farms. How can the author critique the amendments when he does not even understand the application of the bill or the amendments?
2) The remaining issue is the requirement for FDA to establish standards for how farmers grow and harvest crops. If the main objection the author has heard against this is simply the timing of the hearings, then he hasn’t been listening. People can google the term “Leafy Greens Marketing Agreement” to learn about some of the many serious problems with having the government tell farmers how to grow their crops. In brief, small, diverse farms are significantly different from the industrial-scale farms that have caused all of the major outbreaks to date. Many of the provisions that FDA used in the Marketing Agreement, such as exclsuion of wildlife from fields, are both impractical and unnecessary for small, diverse farms.
I spoke at a recent FDA listening session, and a farm intern recorded my statement:http://www.youtube.com/user/FarmAndRanchFreedom#p/a/u/0/pmhn_NKgFs8
Other farmers’ statements are also posted.
So let’s consider who really would be exempt under the proposed amendments. First, facilities that GROSS less than $500,000 would be exempt from the HACCP requirements and subject to limited traceback requirements. When you consider a typical profit margin on a food business, that translates to people who have net profits under $100,000, if they manage to make a profit at all. These businesses are the local bread makers, cheesemakers, jammakers, etc. who sell at local farmers markets and through small, local co-ops and groceries. No major oubreak has ever been caused by these businesses.
Then, consider the farms. The Tester amendments would exempt farms who sell a majority of their produce directly to consumers and other end users (such as restaurants and schools). Again, no major outbreaks have been traced to these farms.
While the state and local laws do vary, there is simply no evidence that they are insufficient to address food safety when applied to small local farms and food processors. These small businesses provide consumers with an alternative to the industrial food supply that has been the source of all of the major foodborne illness outbreaks. Without the Tester amendments, S. 510 could actually reduce food safety by driving small farms and food producers out of business, leaving consumers without the option to buy local, healthy foods.

David Plunkett

People need to read the bill and not the hype. If they did, it would be clear to them that the one-size-fits-all claim doesn’t hold up.
For food processors the bill requires regulations to take into account the various sizes and types of facilities and to be flexible enough for them to comply with the bill’s safety provisions. It also provides small and very small businesses more time to meet safety requirements than is allowed to big business. The preventive controls section is almost entirely oriented toward industry self-regulation, and if the person running the business (small or big) gets to design the plan it is hard to see how that can be one-size-fits-all. It is true the plan must meet some objective standard of being effective but that isn’t a burden; it’s just common sense. Furthermore, the bill specifically prohibits FDA from requiring companies to adopt specific technologies, practices or critical controls. Successful small business people are a smart bunch. I think we can trust them to figure out how to comply with these measures to make their products safe and document that to FDA’s satisfaction.
One thing that needs to be cleared up is that Heather does not have to have a hazard analysis and food safety plan for her onions. Farms are not “facilities” and so are not covered byt he preventive control section of the bill. The produce safety standards are to be the minimum necessary to minimize the risk of serious illnesses from causes associated with the growing and harvesting of produce that is normally eaten raw. These are things a farmer like Heather is going to want to do anyway to keep from making her customers sick. There is no requirement for farmers to do a hazard analysis and write a food safety plan in the bill. (Now, If the farmer is also processing food, and is selling it to a wholesaler for distribution around the country, then yes the processing operation would be required to implement preventive controls. But, this is not required if the farmer is selling the processed goods directly to consumers — as Heather might do at a farmers’ market.) Heather hasn’t described anything she is doing on her farm that is going to bring her under the preventive controls section of the bill. But, she does describe one problem with failing to pass the bill. If we don’t have food safety standards on the farm, then the safety standards will be written by private marketing agreements and retailer contracts. These arrangements will vary from commodity to commodity and retailer to retailer with each insisting on unique provisions like the wildlife requirement she complains about. That will put farmers out of business or keep them so small they can never make a living without keeping a side job in the city.
What will the Tester amendment do that makes it so bad for small business and small farms?
Well first it will open a door for unscrupulous food processors of any size to put consumers at risk. This is because the amendment — while perhaps well-intentioned — is poorly written. If Adjusted Gross Income was a reliable measure of size, then we would not need the Alternative Minimum Tax to make sure Kelloggs and Kraft pay taxes. Anybody with a good accountant can make their company fit within a specified AGI. Also, since the amendment affects “facilities” it is even easier to get around the AGI limit. A facility is a building; not the entire company. So a company with a lot of facilities can have multi-billions of dollars in sales yet not have any one facility with an AGI greater than $500,000.
Second, AGI is an American tax term. How are we going to determine the AGI of foreign companies that don’t file American taxes? A quirk of food import law is that we have to apply the same standard to foreign companies as we do to American companies. (I may not like that, but there is reality to consider.) So, Tester lets foreign companies of every ilk import freely into our country without meeting the basic food safety measures required by the bill. That puts all the pressure back on border inspections and we have seen how effective those are at stopping unsafe food entering the country.
Tester also creates a major health risk that will force buyers for restaurants, hotels and institutions to think twice (or write stringent safety requirements for their suppliers) before they buy local. Its a risk that will haunt small farming if Tester is implemented. Places that serve the public have the potential to make a lot of people sick — and be sued for it. No restaurant or hotel is going to want to tell a court that it ignored the potential risk and purchased from a supplier who was exempt from minimum federal food safety standards. (Do you see how this will lead to more private solutions like the leafy greens agreement?) The issue of sales to institutions is especially bad news. Institutions means schools, hospitals and nurse cares. The very young, the immune compromised, and the very old are the categories of consumers most severely affected by foodborne disease. The three deaths in the spinach outbreak of 2006 were a child and two elderly women. These are the people most likely to eat at schools, hospitals and nurse cares. Given the danger, why would any institution buy food that it can’t guarantee has met minimum federal food safety standards? The Tester amendment poses a very real risk of making local, organic and sustainable food synonymous with unsafe — which would be a real shame. And ultimately, small farms will have only one market — their neighbors — because of the stringent requirements or legal risks of selling into any other.
While the consequences of passing Tester are unintended — they are not unforeseeable. We really need to look closely at S. 510. The bill is designed to protect the public from preventable foodborne disease. It implements the minimum of what we should be doing to make sure that production and processing of food results in a product that is safe for families to eat. I think that is something we should all get behind and support without exception.

John Munsell

This article is correct in that a “One Size Fits All” protocol is incorrect. And, we must be very careful in not ascribing too much value to the Hazard Analysis system to which this article refers, which is HACCP. While Pillsbury-style HACCP is indeed science based and produces consistently wholesome food, USDA-style HACCP is NOT based in science, and has been intentionally implemented in a manner which insulates the huge transnational slaughter facilities from meaningful oversight. Simultaneously, and this is enormously important in the discussion over S. 510, USDA-style HACCP has decimated our domestic countryside of small meat plants. Such plants did not drop federal inspection because of their inability to produce safe meat. Rather, they became so exasperrated in ever-changing USDA demands, most of which are unjustified and have no connection to food safety, that the plant owners walked away. The same sordid scenario is guaranteed to occur once S. 510 is passed as written, and we will have only ourselves to blame as we are unwilling to admit in advance that this federal boon doggle will repeat itself. We will also increase our dependence on imported produce; please don’t attempt to convince me that foreign produce manufacturers have a system “equivalent” to ours. Senator Tester’s ammendments are not only common sense, but necessary.
John Munsell

http://amyunzen.com Amy

Pick on someone your own size, Harry Hamil!

Harry Hamil

Alex, your labeling a website as “extremist” because it wrote “Senate Bill S. 510 Makes it illegal to Grow, Share, Trade or Sell Homegrown Food, or Even to Produce Your Own Food” made me LOL.
The problem the writer on the website has is that s/he believes the plain meaning of words and that laws should be clearly written. What naiveté.
The new subsection 419(a)(1) created by Sec. 105 Standards for Produce Safety states that the Secretary of HHS shall “establish science-based minimum standards for the safe production and harvesting of those types of fruits and vegetables that are raw agricultural commodities for which the Secretary has determined that such standards minimize the risk of serious adverse health consequences or death.” And then, subsection 105(b) follows with “Prohibited Acts- Section 301 (21 U.S.C. 331), as amended by section 103, is amended by adding at the end the following: (vv) The failure to comply with the requirements under section 419.'”
This says the Secretary of HHS, whose department doesn’t know squat about growing crops and animals, sets rules for the “production” and “harvesting” not just for the “sale” of food. That’s what I do when I grow a garden, Alex. It plainly says I will have to obey the rules they set. So, where exactly in the law is this restricted so it can’t be applied as the “extremist website” says?
This is one of the core problems with S 510; it places farmers in the middle of an endless swamp of regulation and rule making. Instead of learning more about farming and ranching, we will have to learn about rules so we can prove we are obeying them.
Big can always pay the price of regulation and rule making. Small frequently cannot.
The even more fundamental problem with what you’ve written, Alex, is that you accept a priori the need for regulation of small ag. But then advocates of the industrial-size-fits-all food safety regulation also declare a priori that what S 510 is “prospective” and “science-based!” What crap and poor analysis.
If any reader wants to actually discuss Sen. Tester’s amendments or S 510, I’ll be happy to do so. Just write me at healthyfoodcoalition@gmail.com and we’ll set up a time to talk on my nickel.

http://www.foodsafetynews.com/contributors/alex-ferguson/ afergeson

Harry,
I was not calling websites extremist because of their stance on S. 510. The sites I was referring to that have carried the headline that I quoted include an Aryan Nation site, a survivalist site, and a conspiracy theorist site, none of which I believe should be dignified here with links, but they can readily be found via a quick Google search.
Regarding your reference to section 419(a)(1), this section is a call for proposed rulemaking. (For more information on just what that entails, see my article entitled “S. 510: Laws without Effective Timelines?”) The revised section does not grant new authority to the Secretary. Rather, it requires the Secretary to initiate proposed rulemaking on a particular topic. This is an administrative agency rule, and thus it follows the process outlined in the Administrative Procedures Act. The proposed rulemaking is required to be flexible enough to apply to various types of entities (page 141, lines 21-24), thus, should a rule be proposed that you feel is unfair to small farms, you would have a strong argument that it was overly-burdensome. No where does the bill say that any proposed rule will be applicable to your ability to grow a garden.
And yes, not only do I accept the need for regulation of small ag, as a consumer I encourage it.

Harry,
I was not calling websites extremist because of their stance on S. 510. The sites I was referring to that have carried the headline that I quoted include an Aryan Nation site, a survivalist site, and a conspiracy theorist site, none of which I believe should be dignified here with links, but they can readily be found via a quick Google search.
Regarding your reference to section 419(a)(1), this section is a call for proposed rulemaking. (For more information on just what that entails, see my article entitled “S. 510: Laws without Effective Timelines?”) The revised section does not grant new authority to the Secretary. Rather, it requires the Secretary to initiate proposed rulemaking on a particular topic. This is an administrative agency rule, and thus it follows the process outlined in the Administrative Procedures Act. The proposed rulemaking is required to be flexible enough to apply to various types of entities (page 141, lines 21-24), thus, should a rule be proposed that you feel is unfair to small farms, you would have a strong argument that it was overly-burdensome. No where does the bill say that any proposed rule will be applicable to your ability to grow a garden.
And yes, not only do I accept the need for regulation of small ag, as a consumer I encourage it.

hhamil

Alex, thanks for the clarification on “extremist websites.” Now, please tell me what they have to do with “What’s wrong with the Tester amendments?”
Thanks for making one of the key points of our arguments about S 510: the FDA is currently not fully using its existing powers so why are we giving it additional ones?
What I hear you saying is this ONLY requires the Secretary to write rules and then restricts how those rules may be written? If so, please give us a cite for the original actual grant of authority.
How is an entirely new section a “revised” section? If it is a “revised” section, why isn’t there something in S 510 saying what it is revising?
There is no restriction in what I quoted to crops grown for sale. They apply to whatever the Secretary has determined needs them. This is comprehensive; therefore an exemption is needed.
My statement about the acceptance of an a priori need for the regulation of small ag was poorly worded. What I intended to get at was this type of regulation–Washington bureaucrats telling farmers HOW to farm because that’s exactly what this does. And why? Because there’s a widespread failure on the part of fruit and vegetable farmers to fulfill their duties to our customers? No. Is because we pose a demonstrable, material threat to the public health? No.
So, Alex, do you favor a law that will cut the local, healthy food movement and much of small ag off at the knees?
Why do you favor a law that choke off the flow of new farmers because they can’t make a full-time living except in industrial agriculture?
Why do you favor a law that will destroy the amazing foodtopia that we have built here in Buncombe County, NC?
Why do you favor a law that will destroy Farmers Fresh Market in Rutherford County, NC which is the only source of significant new employment in the county that is clearly the worst off in NC, a state with over 11% official unemployment? (And it won its creator the “Purpose Prize” last year.)
Why are you favor a law that will wipe out most of the healthiest food in American and keep what’s left out of the hands of the poor?
Why is it that you ignore the horrible economic and societal cost of the endless swamp of rule making this will create?
And, finally, why do you advocate entrusting the FDA with unprecedented new powers when its incompetence is well known by your law firm and has, in the last 10 years alone, cost tens of thousands of farmers hundreds of millions of dollars?

hhamil

For the benefit of any readers who don’t know:
Judith McGeary is the Executive Director of Farm and Ranch Freedom Alliance (http://farmandranchfreedom.org/). She helps coordinate the efforts of over 115 groups in support of the Tester amendments. I have the privilege of working with her.
David Plunkett is the Senior Attorney in the Food Safety department of the Center for Science in the Public Interest (www.cspinet.org/) which is, in turn, part of the Make Our Food Safe coalition (www.makeourfoodsafe.org/).
I am a small grower, distributor and retailer of local, healthy food in WNC. Lots more info about me can be found on this site by searching my name or Googling me..

hhamil

Mr. Plunkett, I have read the sections of S 510 involved in these issues and it is clear to me the “one-size-fits- all claim” understates the problem. I have no question that “industrial-size-fits-all” is a much more accurate characterization.
I will address only that misrepresentation of all of the ones you made. If anyone wants me to point out more, please write me at healthyfoodcoalition@gmail.com.
You wrote, “For food processors the bill requires regulations to take into account the various sizes and types of facilities and to be flexible enough for them to comply with the bill’s safety provisions.”
As you well know, the regulations most troublesome for “processors” and other “facilities” are in Sec. 103. Hazard Analysis & Risk-based Preventive Controls (HARPC plans). I have just re-read that section again. It applies to ALL packers, processors and distributors that store any food no matter how long REGARDLESS OF SIZE.
The only reference I can find that is even close to what you said above actually reads, “CONTENT – The regulations promulgated under paragraph (1) shall provide sufficient flexibility to be applicable in all situations, including in the operations of small businesses.” [See 103(b)(2)] “Flexibility to be applicable” only means that they can be applied. It doesn’t say anything about appropriateness or affordability.
Let me give an example.
There is a goat milk cheese maker named Pug’s Leap Farm near Healdsburg, CA that is already selling out because of S 510/HR 2749. One of the owners, Pascal Destandau, used his 20+ years in the personal care products business (where he had to work within the parameters of HACCP) went to New South Wales, Australia for plausible regs & estimated the cost of implementing it for his Grade B goat cheese operation. It will be about $50,000 ANNUALLY. He and his partner grossed about $85,000 last year & lost about $8500. It will cost that much OUT OF POCKET because they already work an average of 65 hours each per week & can’t do the extra 25 – 30 hours of work required each & every week. Also, because Pug’s Leap would be hiring its first employee, they would have to add a new ADA compliant bathroom, a break room, a changing room & an additional septic system. Plus, there is the new equipment and mandatory training required by “the plan.”
How to fund it initially? Borrow $200,000.
No matter how long S 510 gives Pug’s Leap to comply, it cannot afford to comply. Being wise business people, Pascal and, his partner, Eric are selling out.
Pascal estimates that the smallest cheesemaker that could afford just that one part of S 510 would need to produce 100,000 pounds of cheese. As Pug’s Leap produced about 5,000 pounds last year, it obviously cannot survive. Thus, it is for sale. Every potential buyer has intended to close the farm and open a vineyard/winery.
So, I ask, “Where will the many customers who have bought Pug’s Leap cheese be able to buy cheese?” My answer is from other artisan cheesemakers until they, too, realize the hopelessness of their plight. Then, the customers will have to go back to industrial ag produced cheese or buy imported cheese that won’t have to jump through all of these hoops because of the variances written into S 510.
Mr. Plunkett, please quit misrepresenting what S 510 contains and the impact that it will have.

Harry Hamil

Alex, thanks for the clarification on “extremist websites.” Now, please tell me what they have to do with “What’s wrong with the Tester amendments?”
Thanks for making one of the key points of our arguments about S 510: the FDA is currently not fully using its existing powers so why are we giving it additional ones?
What I hear you saying is this ONLY requires the Secretary to write rules and then restricts how those rules may be written? If so, please give us a cite for the original actual grant of authority.
How is an entirely new section a “revised” section? If it is a “revised” section, why isn’t there something in S 510 saying what it is revising?
There is no restriction in what I quoted to crops grown for sale. They apply to whatever the Secretary has determined needs them. This is comprehensive; therefore an exemption is needed.
My statement about the acceptance of an a priori need for the regulation of small ag was poorly worded. What I intended to get at was this type of regulation–Washington bureaucrats telling farmers HOW to farm because that’s exactly what this does. And why? Because there’s a widespread failure on the part of fruit and vegetable farmers to fulfill their duties to our customers? No. Is because we pose a demonstrable, material threat to the public health? No.
So, Alex, do you favor a law that will cut the local, healthy food movement and much of small ag off at the knees?
Why do you favor a law that choke off the flow of new farmers because they can’t make a full-time living except in industrial agriculture?
Why do you favor a law that will destroy the amazing foodtopia that we have built here in Buncombe County, NC?
Why do you favor a law that will destroy Farmers Fresh Market in Rutherford County, NC which is the only source of significant new employment in the county that is clearly the worst off in NC, a state with over 11% official unemployment? (And it won its creator the “Purpose Prize” last year.)
Why are you favor a law that will wipe out most of the healthiest food in American and keep what’s left out of the hands of the poor?
Why is it that you ignore the horrible economic and societal cost of the endless swamp of rule making this will create?
And, finally, why do you advocate entrusting the FDA with unprecedented new powers when its incompetence is well known by your law firm and has, in the last 10 years alone, cost tens of thousands of farmers hundreds of millions of dollars?

Harry Hamil

For the benefit of any readers who don’t know:
Judith McGeary is the Executive Director of Farm and Ranch Freedom Alliance (http://farmandranchfreedom.org/). She helps coordinate the efforts of over 115 groups in support of the Tester amendments. I have the privilege of working with her.
David Plunkett is the Senior Attorney in the Food Safety department of the Center for Science in the Public Interest (www.cspinet.org/) which is, in turn, part of the Make Our Food Safe coalition (www.makeourfoodsafe.org/).
I am a small grower, distributor and retailer of local, healthy food in WNC. Lots more info about me can be found on this site by searching my name or Googling me..

Harry Hamil

Mr. Plunkett, I have read the sections of S 510 involved in these issues and it is clear to me the “one-size-fits- all claim” understates the problem. I have no question that “industrial-size-fits-all” is a much more accurate characterization.
I will address only that misrepresentation of all of the ones you made. If anyone wants me to point out more, please write me at healthyfoodcoalition@gmail.com.
You wrote, “For food processors the bill requires regulations to take into account the various sizes and types of facilities and to be flexible enough for them to comply with the bill’s safety provisions.”
As you well know, the regulations most troublesome for “processors” and other “facilities” are in Sec. 103. Hazard Analysis & Risk-based Preventive Controls (HARPC plans). I have just re-read that section again. It applies to ALL packers, processors and distributors that store any food no matter how long REGARDLESS OF SIZE.
The only reference I can find that is even close to what you said above actually reads, “CONTENT – The regulations promulgated under paragraph (1) shall provide sufficient flexibility to be applicable in all situations, including in the operations of small businesses.” [See 103(b)(2)] “Flexibility to be applicable” only means that they can be applied. It doesn’t say anything about appropriateness or affordability.
Let me give an example.
There is a goat milk cheese maker named Pug’s Leap Farm near Healdsburg, CA that is already selling out because of S 510/HR 2749. One of the owners, Pascal Destandau, used his 20+ years in the personal care products business (where he had to work within the parameters of HACCP) went to New South Wales, Australia for plausible regs & estimated the cost of implementing it for his Grade B goat cheese operation. It will be about $50,000 ANNUALLY. He and his partner grossed about $85,000 last year & lost about $8500. It will cost that much OUT OF POCKET because they already work an average of 65 hours each per week & can’t do the extra 25 – 30 hours of work required each & every week. Also, because Pug’s Leap would be hiring its first employee, they would have to add a new ADA compliant bathroom, a break room, a changing room & an additional septic system. Plus, there is the new equipment and mandatory training required by “the plan.”
How to fund it initially? Borrow $200,000.
No matter how long S 510 gives Pug’s Leap to comply, it cannot afford to comply. Being wise business people, Pascal and, his partner, Eric are selling out.
Pascal estimates that the smallest cheesemaker that could afford just that one part of S 510 would need to produce 100,000 pounds of cheese. As Pug’s Leap produced about 5,000 pounds last year, it obviously cannot survive. Thus, it is for sale. Every potential buyer has intended to close the farm and open a vineyard/winery.
So, I ask, “Where will the many customers who have bought Pug’s Leap cheese be able to buy cheese?” My answer is from other artisan cheesemakers until they, too, realize the hopelessness of their plight. Then, the customers will have to go back to industrial ag produced cheese or buy imported cheese that won’t have to jump through all of these hoops because of the variances written into S 510.
Mr. Plunkett, please quit misrepresenting what S 510 contains and the impact that it will have.

Doc Mudd

Mr. Hamil reports, of Msrs. Pascal and Eric: *”He and his partner grossed about $85,000 last year & lost about $8500.”* *”…they already work an average of 65 hours each per week”.** “Being wise business people, Pascal and, his partner, Eric are selling out.”* What, exactly, does S.510 have to do with this business failure, Harry?
.
To your question, Mr. Hamil, “Where will the many customers who have bought Pug’s Leap cheese be able to buy cheese?”, I am pleased to report one can purchase cheese practically anywhere. It’s only cheese, for pity’s sake. Every supermarket has some cheese to sell, it is for sale over the internet, even WalMart (fast becoming my favorite natural food outlet) has cheese for sale…tons and tons of it. In fact, for the past year now the nation is glutted with cheese and the price is low. Please, please stop making so much cheese and eat more of it!
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Enough disingenuous objection, already. Let’s stop kidding around and safeguard our food supply — pass S.510 into law!!!

dangermaus

All this talk about standards and regulations is moot. Anyone who is even remotely involved with food production knows that inspections are capricious at best and only really threaten the existence of small farmers (because they don’t have lawyers, and the big guys do). USDA inspectors are not looking out for our health, they’re out to make themselves look like they’re looking out for our health so they can feel and act like they’re smarter than consumers and retire at 55. Maybe we need two food distribution options, a federally-regulated one and a free one where consumers choose what the want… But stop limiting our freedom of choice with these ineffectual regulations that increasingly assume that every farmer has a capital budget of hundreds of thousands of dollars. Finally, avoid buying food from farmers who won’t let you visit their land – including all the big agribusiness outfits! Why anyone thinks the USDA is less incompetent the DoD, EPA, or any of the other useless ministries of waste is beyond me.